An intermittent urinary catheter assembly

ABSTRACT

A urinary catheter assembly is provided. The catheter assembly has a first outer package (20), which contains a second inner package (1). The second inner package includes a hydrophilic coated, intermittent catheter 82) and liquid swelling medium. The first outer package is made of a first material with a WVTR value between 1 and 6 g/(m2·24 h) and the second inner package is made of a second material with a second WVTR value below 3 g/(m2·24 h). An intermediate cavity (25) is defined inside the first outer package, but outside the second inner package. The first and second WVTR-values are balanced in such a way that the relative humidity (RH) is below 90% in the intermediate cavity. This prevents condensation on the inner surface of the first outer package and on the outer surface of the second inner package.

The disclosure relates to an intermittent urinary catheter assembly.

BACKGROUND

Users of intermittent catheters may have become incontinent due to aspinal cord injury, a disease such as multiple schlerosis or spinabifida or other factors resulting in the user losing control of thebladder function. Many users also have poor hand dexterity as a resultof their condition.

An intermittent urinary catheter is used 4-6 times a day forintermittently draining the bladder of a user. During each emptying, theintermittent urinary catheter sits in urethra for 10-15 minutes or less.Such a catheter has an ability to slide easily through the urethrawithout exposing the urethral walls to any risk of damage. One way ofdoing this is by imparting an extremely low friction character to atleast the part of the surface of the catheter which is introduced intothe urethra. The low friction surface character is obtained byincorporating onto the relevant part of the catheter a hydrophiliccoating and exposing this coating to contact with a swelling mediumprior to use.

SUMMARY OF THE INVENTION

Embodiments relate to a urinary catheter assembly comprising a firstouter package of a first material, where the first material has a firstwater vapour transmission rate (WVTR) determined according to ASTM F1249at a relative humidity of 90% and a temperature of 38° C. between 1g/(m²·24 h) and 6 g/(m²·24 h). The first outer package contains a secondinner package of a second material, and the second material has a secondwater vapour transmission rate (WVTR) determined as described below at arelative humidity of 65% RH and a temperature of 30° C. below 3 g/(m²·24h). An intermediate cavity is defined as an area inside the first outerpackage and outside the second inner package. The second inner packagedefines an enclosure, which contains an intermittent urinary catheterwith a hydrophilic coating and a swelling medium. The first water vapourtransmission rate and the second water vapour transmission rate arebalanced in such a way that the RH value is below 90% in theintermediate cavity

BRIEF DESCRIPTION OF THE DRAWING

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIGS. 1 and 2 illustrate schematic drawings of urinary catheterassemblies as described

FIGS. 3 to 5 illustrate cross-sectional views of a second inner package

FIG. 6 illustrate a cross-sectional view of a part of a second innerpackage

FIG. 7 illustrate a cross-sectional view of a layered structure of amaterial useful in a second inner package

FIG. 8 illustrate a perspective view of a second inner package in aready for insertion state

FIGS. 9A and 9B illustrate upper and lower fixtures for use in testingof collapse-force

FIGS. 10A-10C illustrate a second inner package mounted in a test-rigfor testing of collapse-force

FIG. 11 illustrates weight loss per day as a result of evaporationthrough a material

FIGS. 12 and 13 illustrate the balance between shelf life and thehumidity level in a double package.

DETAILED DESCRIPTION

Embodiments relate to a urinary catheter assembly comprising a firstouter package of a first material, the first outer package contains asecond inner package of a second material, an intermediate cavitydefined as area inside the first outer package and outside the secondinner package, the second inner package defining an enclosure, theenclosure containing an intermittent urinary catheter with a hydrophiliccoating and a swelling medium, wherein the permeability of the firstouter package and the permeability of the second inner package isbalanced in such a way that the RH value is 100% inside the innerpackage and the RH value is below 90% in the intermediate cavity.

Embodiments relate to a urinary catheter assembly comprising a firstouter package of a first material, the first material having a firstwater vapour transmission rate (WVTR) determined according to ASTM F1249at 90% RH and 38° C. between 1 g/(m²·24 h) and 6 g/(m²·24 h), the firstouter package contains a second inner package of a second material, thesecond material having a second water vapour transmission rate (WVTR)measured as described below at 65% RH and 30° C. below 3 g/(m²·24 h);

an intermediate cavity defined as an area inside the first outer packageand outside the second inner package, the second inner package definingan enclosure, the enclosure containing an intermittent urinary catheterwith a hydrophilic coating and a swelling medium;

wherein the first water vapour transmission rate and the second watervapour transmission rate are balanced in such a way that the RH value isbelow 90% in the intermediate cavity and wherein the second innerpackage is made of a multilayer film material comprising layers ofPolyethylene (PE) and layers of Styrene-IsoButylene-Styrene (SIBS)and/or layers of combinations of PE and SIBS.

Embodiments further relate to a urinary catheter assembly comprising afirst outer package of a first material, the first material having afirst water vapour transmission rate (WVTR), the first outer packagecontains a second inner package of a second material, the secondmaterial having a second water vapour transmission rate (WVTR);

an intermediate cavity defined as an area inside the first outer packageand outside the second inner package, the second inner package definingan enclosure, the enclosure containing an intermittent urinary catheterwith a hydrophilic coating, and a swelling medium;

wherein the relationship between the first and second water vapourtransmissions are such that they fulfil the following equations:

  BF(outer) = WVTR(outer) ⋅ A(outer) ⋅ p(outer)  BF(inner) = WVTR(inner) ⋅ A(inner) ⋅ p(inner)${{{RH}({cavity})} = {{{{RH}({storage})} + {\left( {100 - {{RH}({storage})}} \right) \cdot \frac{\frac{1}{{BF}({outer})}}{\frac{1}{{BF}({outer})} + \frac{1}{{BF}({inner})}}}} < {90\%}}};$

wherein BF(outer) is the barrier flow through the first outer packagegiven in g/24 h, BF(inner) is the barrier flow through the second innerpackage given in g/24 h, WVTR(outer) is the first water vapourtransmission rate and WVTR(inner) is the second water vapourtransmission rate, A(outer) is the surface area of the first outerpackage, A(inner) is the surface area of the second inner package,p(outer) is the difference in RH-value between the ambience and theintermediate cavity (i.e. across the first outer package), and p(inner)is the difference in RH-value between the second inner package and theintermediate cavity (i.e. across the second inner package). RH(cavity)is the RH-value in the intermediate cavity and RH(storage) is theRH-value at the storage location external to the first outer package.

Urinary catheter assemblies as disclosed here are provided with a firstouter package with a first permeability and a second inner package witha second permeability, where the permeability may be defined by usingthe water vapour permeability (WVTR) determined as described below. Thismethod provides a value for the WVTR at 65% RH and 30° C. Otherpossibilities for determining WVTR exists; in this disclosure alsodetermining WVTR according to ASTM F1249 at 90% RH and 38° C. is used.By ASTM F1249 is meant herein ASTM F1249-13.

By balancing the first and second WVTR values of the first outer packageand the second inner package as mentioned above, a urinary catheterassembly having an inner package which is dry on an outer surface isobtained, thereby allowing the second inner package to be easily handledby a user. This is because any liquid inside the outer package butoutside the inner package will diffuse out of the assembly through theouter package within a short period of time, such as 1 day or shorter.The diffusion is obtained by having the level of RH inside the outerpackage and outside the inner package below 90%. The catheter assemblywill thus have a balanced loss of swelling medium over time. However,the loss of swelling medium is always so low that the intermittenturinary catheter is fully hydrated during the storage period.

By selecting the first outer package to have the abovementionedpermeability (the first WVTR values), an outer package of a softer, lessrigid material can be achieved. By softer and less rigid is meant thatthe material does not crinkle and make a noise, when touched, and thatthe edges of the material are less sharp and thereby less prone to chafethe user handling the first outer package. Furthermore, the outerpackage may be made without an aluminium-layer and will therefore bemore environmentally friendly.

In the following, whenever referring to a proximal end of an element ofthe intermittent urinary catheter assemblies, the referral is to the endadapted for insertion. Whenever referring to the distal end of anelement, the referral is to the end opposite the insertion end. In otherwords, the proximal end is the end closest to the user, when theintermittent urinary catheter is to be inserted and the distal end isthe opposite end—the end furthest away from the user when the urinarycatheter is to be inserted. The same definitions apply to the secondinner package.

The intermittent urinary catheter comprises a main tubular partextending from the distal end to the proximal end. The tip portion ispositioned at a proximal end of the catheter and comprises an eyeletpart with eyelets and a proximal part proximal of the eyelet part. Theproximal part may comprise a proximal rounded closed end of the tubularpart. The eyelets serve the purpose of letting urine enter into theinner lumen of the tube. The tip portion may be a Nelaton tip, where theproximal end is simply closed off providing a half-spherical closed end.The tip portion may be integrally moulded with the main tubularpart—either as 1 component or 2 component moulding—or it may be providedas a separate element and then attached to the main tubular part, e.g.by welding or adhering. The tip portion may also be made by modifyingthe main tubular part, i.e. by punching the eyelets and rounding theproximal end to close it off.

The urinary catheter may be made of a polyurethane material (PU) orpolyvinyl chloride (PVC) or poly-olefins such as a polyethylene (PE).

Usually urinary catheters used as intermittent urinary catheters arefrom size 8 FR to size 16 FR. FR (or French size or Charriere (Ch)) is astandard gauge for catheters approximately corresponding to the outercircumference in mm. More accurately, the outer diameter of the catheterin mm corresponds to FR divided by 3. Thus 8 FR corresponds to acatheter with an outer diameter of 2.7 mm and 16 FR corresponds to acatheter with an outer diameter of 5.3 mm.

The intermittent urinary catheters may prior to use be provided with ahydrophilic coating so as to impart a low-friction insertion.

The hydrophilic coating may be provided only on the insertable part ofthe catheter. The hydrophilic surface coating is of the kind which, whenhydrated or swelled using a swelling medium, reduces the friction on thesurface area of the catheter which is intended to be inserted into theurinary channel of a user corresponding to the insertable part of thecatheter.

An intermittent hydrophilic catheter differs from an indwelling catheterin that the hydrophilic surface coating of such a catheter is notsuitable for indwelling use, because the surface coating tends to stickinside the mucosa of the urethra if left inside the body for a periodexceeding 5-20 minutes, due to the hydrophilic coating transforming frombeing highly lubricious when fully wetted (95% weight water) to beingadhesive when the hydration level of the coating is reduced (<75% weightwater). Furthermore, intermittent implies repeated and short term use,which means that a user of intermittent catheters has to insert acatheter 4 to 6 times a day and leave them sitting in the urethra for ashort period (<20 minutes) only. It is therefore an advantage if anintermittent catheter has a very (extremely) lubricious surface withlow-friction properties. Moreover, for an intermittent catheter, theinsertion of the catheter has to be simple and easy to handle, even forusers with low hand-dexterity.

The urinary catheter assembly comprises a medium for activating thehydrophilic surface coating of the catheter. The activating medium is awater based substance, such as sterile water, saline-solution, or anywater based liquid.

The storage period of an assembly as above is typically at least 1 year,but may be longer such as 2 or 3 years.

In the intermittent urinary catheter assemblies described here, theswelling medium is in direct contact with the coating during the storageperiod. This means that the swelling medium is contained inside thesecond inner package in contact with the hydrophilic coating of theintermittent urinary catheter during the storage period.

For the purpose of this disclosure a film-material is defined as amaterial having a thickness of below 200 μm. The thickness of thefilm-material may influence the ability of the second inner package tofunction as an insertion aid. Embodiments relate to film-materialshaving a thickness of below 150 μm.

This disclosure mentions an intermediate cavity, which is defined as thearea or volume between the first outer package and the second innerpackage.

A collapse-force as mentioned in this disclosure is the force used tocollapse the second inner package enclosing the intermittent urinarycatheter, in case the second inner package is used as an insertion aid.In this case, the second inner package will be made as tubular elementof film material and will have a maximum diameter of the tubular elementof around 10 mm, so that the enclosure inside the second inner packagenarrowly surrounds the intermittent urinary catheter. The collapse-forceis defined as the force used to collapse a narrowly surrounding secondinner package in such a way that 30 cm of a male catheter is exposedfrom a distal eyelet in the insertion tip end. Tests have shown that ifthe collapse-force for exposing 30 cm of a male catheter is below 6 N,then users will find it easy to collapse the second inner package. Thisis particularly advantageous for users having poor hand dexterity. Inthe case that the male catheter has a length of approximately 40 cm, thetubular element of film material may have a length, in a fully extendedstate, of approximately 34 cm. In this case the collapse-force ismeasured when the tubular element has collapsed from a fully extendedlength of approximately 34 cm to a collapsed length of approximately 4cm. Accordingly, the tubular element is collapsed to a length which isapproximately 12% of the fully extended length.

Embodiments relate to a first outer package being made of afilm-material with a thickness below 200 μm. The first outer package maybe made of a multilayer film-material.

Embodiments relate to a first outer package of film-material that iswelded along the edges. In areas, where the package is contemplated tobe opened, the welding may be adapted for this purpose, e.g. by apeel-welding technique.

Embodiments relate to the second inner package being of tubular form andproviding a close-fit about the catheter. Embodiments relate to thesecond inner package having a diameter of 15 mm, but may be less such as12 mm or 10 mm or even 9 mm. This is to be correlated to the diameter ofthe catheter, which is typically between 2.7 mm and 6 mm. Thus,embodiments provide for a volume inside the second inner package (i.e.the volume of the enclosure), which is large enough to contain thecatheter as well as the required swelling medium. The amount of swellingmedium may be between 5 and 20 ml such as around 15 ml or 16 ml.

Embodiments relate to an intermittent urinary catheter assembly asabove, wherein the second inner package comprises a handle slidinglydisposed on the intermittent urinary catheter and a collapsible andflexible tubular film element, which is attached to the handle and whichis configured to cover the intermittent urinary catheter from an outletto an insertion tip in an extended configuration. The tubular filmelement is attached to a connector at the outlet. The connector andhandle are configured to be attached to each other in a detachablemanner, so that when the connector and handle are attached to eachother, the intermittent urinary catheter is encapsulated completelyinside an enclosure provided by the second inner package comprising thetubular film element, the handle and the connector.

By being configured to cover the urinary catheter from the outlet to theinsertion tip is meant that the tubular film element covers a majorityof the longitudinal extent of the intermittent urinary catheter in anextended configuration. By a majority is meant that the second innerpackage covers more than 90% of the length of the intermittent urinarycatheter from the connector towards the tip in the longitudinaldirection, such as more than 95% or 97% of the length. The connector andhandle are typically attached to each other in a storage condition, andin that storage condition, the intermittent urinary catheter isencapsulated completely inside the enclosure provided by the secondinner package. In a use condition or extended configuration of theassembly, the connector and handle are detached from each other and,typically, the liquid will be drained out from the cavity. The storagecondition may also be known as the closed configuration of the secondinner package and the use condition may be known as the openconfiguration of the second inner package.

One advantage of the embodiment is that the second inner packageprovides a complete enclosure for the intermittent urinary catheter, sothat in the storage condition, the sterility is not compromised in anyway—even as the second inner package with the intermittent urinarycatheter inside the storage cavity is removed from first outer package.The user may drop the second inner package on the floor or even into thetoilet, without compromising the sterility of the intermittent urinarycatheter itself. In particular, the insertion tip is protected frombeing contaminated by contact with anything unclean as long as theconnector is connected to the handle. Furthermore, when the intermittenturinary catheter is to be used, the user simply detaches the connectorfrom the handle. Following unfolding or unrolling of the tubular filmelement of the second inner package with the intermittent urinarycatheter inside, the intermittent urinary catheter is ready to be used.The second inner package further provides the user with the possibilityof gripping and holding the urinary catheter so that it is easier touse. Thereby, the catheter itself can be made of a softer and morebendable material than a catheter that is to be inserted in a straightposition.

In an assembly as described above, the user of the assembly only has tohandle one item. Users of intermittent urinary catheter assemblies mayhave reduced hand dexterity making it difficult for them to handleseveral items. Therefore, it is an advantage that no extra items (e.g.caps or closures) need to be handled. Furthermore, when the connectorand handle are separated, each of these two parts provides an intuitivelocation for handling the catheter, which can be done withoutcompromising the sterility of any part of the catheter.

Embodiments relate to the second inner package being closed with a firstclosure in the proximal end. Embodiments relate to the second innerpackage being closed with a second closure in the distal end.Embodiments relate to the first closure being a plug. Embodiments relateto the second closure being a plug. Embodiments relate to the firstclosure being a peel-welded closure. Embodiments relate to the secondclosure being a peel-welded closure.

A material suitable for the first outer package is a multilayer filmmaterial including Polyethylene (PE).

Embodiments relate to a first outer package being made of a multiplelayer film material of a laminate of Polyethylene terephthalate (PETP)and Polyethylene (PE).

Embodiments relate to a first outer package being made of a multiplelayer film-material of a laminate of PETP and PE.

Embodiments relate to a second inner package made of a multilayer filmmaterial comprising layers of PE and layers ofStyrene-IsoButylene-Styrene (SIBS). The multilayer film material mayalso comprise layers with a combination of PE and SIBS.

In an embodiment, the material of the second inner package is a 5 layerfilm-material comprising a SIBS layer in the middle, which on each sideis covered by a layer made of PE and SIBS and where the outer layers aremade of PE.

Including SIBS in the material of the second inner package has theadvantage of providing a good impermeability (a low second WVTR value)in combination with a low collapse-force.

Embodiments relate to a second inner package made of a film material ofPolyethylene. Polyethylene may be used if the film material is thickerthan 50 μm. Polyethylene in thinner material may not have the desiredpermeability.

Embodiments relate to a first outer package made of a multiple layerfilm material of a laminate of Polyethylene terephthalate (PETP) andPolyethylene (PE) and a second inner package made of a 5 layerfilm-material comprising a SIBS layer in the middle, which on each sideis covered by a layer made of PE and SIBS and where the outer layers aremade of PE

Embodiments relate to a first outer package made of a multiple layerfilm material of a laminate of Polyethylene terephthalate (PETP) andPolyethylene (PE) and a second inner package made of Polyethylenethicker than 50 μm.

Embodiments relate to a first outer package made of a multiple layerfilm material of a laminate of Polyethylene terephthalate (PETP) andPolyethylene (PE) and a second inner package made of a 5 layerfilm-material comprising a SIBS layer in the middle, which on each sideis covered by further SIBS layers and where the outer layers are made ofPE.

Embodiments relate to the intermittent urinary catheter being amale-catheter meaning that the length of the catheter exceeds 30 cm.

Embodiments relate to an intermittent urinary catheter assembly asabove, wherein the second inner package is useable as an insertion aid.The second inner package thus comprises a tubular film element, which iseasily collapsible to an extent where at least 30 cm from the proximalend of a male catheter can be exposed without noticeable resistance.

In embodiments, the collapse-force used to compress the second innerpackage to the extent where at least 30 cm is exposed is below 6 N.Thereby users having poor hand dexterity will find it unproblematic tocollapse the second inner package 30 cm. In embodiments, thecollapse-force used to compress the second inner package to the extentwhere at least 30 cm is exposed is below 3 N. Having a collapse-forcebelow 3 N provides for a very easily collapsible second inner packageand thereby an assembly that is very easy to use for users havingdexterity problems.

It is an advantage to provide a second inner package which, on the onehand, is collapsible in the manner described above, thereby allowing itto be easily used as an insertion aid, even for user having dexterityproblems, and which on the other hand has a sufficiently low watervapour transmission rate to ensure a required shelf life of theassembly. Furthermore, the water vapour transmission rate of the firstouter package should be sufficiently high to ensure that water vapourentering the intermediate cavity through the second inner packagediffuses out of the assembly, through the first outer package, within ashort period of time, thereby ensuring that the outer surface of thesecond inner package remains dry, thereby allowing it to be easilyhandled by the user.

In an embodiment, the tip portion is a flex tip. In this type ofembodiment, the tip portion of the intermittent urinary cathetercomprises, from the distal end of the tip portion, an eyelet part witheyelets for letting urine into the inner lumen of the catheter, anintermediate part, where the catheter diameter is decreased with respectto the diameter of the remaining part of the catheter, and a proximalpart having a bulb with a diameter close to or exceeding the diameter ofthe tubular part of the catheter. The bulb may also have a diameter thatis slightly less than the diameter of the tubular part of the catheter.The bulb may be close to spherical in shape or may be slightly elongatedand shaped as an olive or droplet. This type of tip portion may beuseful for male users to guide the catheter around the bend in theurethra at the prostate.

In embodiments, where the second inner package includes a handleattachable to the connector, this second inner package allows the tipportion to be protected inside the connector without being bend. Aflexible tip portion is adapted to bend easily—and because of thevisco-elasticity of the material, the tip portion will have a tendencyto deform permanently into a curved position if being subjected tobending for a prolonged period of time. This means that such a bend inthe tip portion may be difficult, if not impossible to straighten outagain, when the catheter is to be used. Thereby, the catheter will bedifficult to insert during the straight part of the urethra.

The eyelets will influence the bending stiffness of the catheter in sucha way that the eyelet part will have a reduced bending stiffnesscompared to the main tubular part of the catheter. The intermediate partmay have a diameter that is decreased to such an extent that the bendingstiffness of this part is between 60% and 80% of the bending stiffnessof the main tubular part of the catheter. This reduced diameter andresulting reduced bending stiffness assist in preventing the catheterfrom kinking at the eyelets, because the deflection of the catheter willbe more evenly distributed, when the intermediate part of the catheteris less rigid (has a lower bending stiffness) than the eyelet part.

In an embodiment, when the intermittent urinary catheter is straightenedout, the second inner package does not completely cover the insertiontip, but up to 10 mm of the tip portion projects beyond the proximal endof the handle. In other words, a major portion of the catheter iscovered by the second inner package. This has the effect that theproximal end of the tip portion is immediately visible and accessiblefor insertion into the urethra, whereas the eyelet part with the eyeletswill still be positioned inside the handle. Having the eyelets insidethe protection of the handle is an advantage, because the catheter ismore likely to kink at the eyelets than at other cross-sections alongthe length of the catheter. So the user can initiate insertion of theintermittent urinary catheter into the urethra and still support theeyelet part of the urinary catheter by squeezing the handle into contactwith this part.

Embodiments relate to a urinary catheter assembly comprising a firstouter package as described above and a second inner package as describedearlier and being provided in an annular closed-loop configurationcontained inside the first outer package. In these embodiments, thevolume of the first outer package has to be large enough to contain theclosed-loop configuration of the second inner package. This large volumeinfluences the level of the first WVTR value, which should be selectedin the lower end of the range mentioned above, i.e. between 1 g/(m²·24h) and 3 g/(m²·24 h). As an example of a first outer package of thistype is a first outer package having a surface area of approximately37000 mm².

Embodiments relate to a urinary catheter assembly comprising a firstouter package as described above and a second inner package as describedearlier and being provided in rolled-up configuration with twoconvolutions. In these embodiments, the volume of the first outerpackage may be reduced compared to other embodiments. This reducedvolume influences the level of the first WVTR value, which may then beselected in the higher end of the range mentioned above, i.e. between 4g/(m²·24 h) and 6 g/(m²·24 h). As an example of a first outer package ofthis type is a first outer package having a surface area ofapproximately 20500 mm².

DETAILED DESCRIPTION OF THE DRAWING

Embodiments, and features of the various exemplary embodiments describedin this application, may be combined with each other (“mixed andmatched”), unless specifically noted otherwise.

FIG. 1 illustrates a schematic view of a urinary catheter assembly witha second inner package 1 packed and stored in a first outer package 20.In this embodiment, the first outer package 20 is made of film-materialwelded along the edges to provide an enclosure 21 in which, theintermittent urinary catheter (not visible) including the tubular filmelement 7 is stored during storage. The intermediate cavity 22 is thearea or volume inside the first outer package 20 but outside the secondinner package 1. In this storage configuration, the first outer packagehas to have a volume large enough to contain the second inner package ina simple, annular closed configuration.

FIG. 2 illustrates a schematic view of another storage configuration ofa urinary catheter assembly. The second inner package 1 is in thisconfiguration rolled-up in in two convolutions inside the first outerpackage 20. In this storage configuration, the first outer package 20can have a reduced volume compared to FIG. 1, because the second innerpackage 1 is rolled-up into two convolutions. The second inner package 1provides an enclosure 24 for the urinary catheter. The intermediatecavity 25 outside of the second inner package 1 and inside the firstouter package 20 is also illustrated.

FIG. 3 illustrates a cross-sectional view of an embodiment of a secondinner package 1 of a urinary catheter assembly, when it is ready to beused. The second inner package 1 includes an intermittent urinarycatheter 2, extending from a proximal insertion end 3 to a distal endcomprising an outlet 4. The proximal end 3 includes a tip portion 5 witheyelets 6 for letting urine enter into the catheter. The second innerpackage 1 further includes a tubular film element 7 extending between ahandle 8 and a connector 9. The tubular film element 7 is collapsible asthe handle 8 is slid along the catheter 2, e.g. during insertion. Theconnector 9 includes a first snap-fit means 10 configured to cooperatewith a complementary second snap-fit means 11 on the handle. The secondsnap-fit means 11 may be in the form of a resilient flange configuredfor snapping behind a first snap-fit means in form of a flange 10 on theconnector.

FIG. 4 illustrates a cross-sectional view a second inner package 1 in acollapsed configuration, that is when the intermittent urinary catheteris inserted into the urethra. In use, the user grips the handle 8 andpull the tubular film element 7 backwards over the intermittent catheterin the direction of the connector 9. The tubular film element 7 of thesecond inner package 1 is collapsible to an extent to only providelimited resistance to being collapsed in front of the connector, as itis described elsewhere in this disclosure, i.e. it has a lowcollapse-force, e.g. below 6 N or even below 3 N. The figure alsoillustrates the eyelets 6 in the tip portion 5 in the proximal end 3 ofthe intermittent urinary catheter.

FIG. 5 illustrates a cross-sectional view of a second inner package 1 ina storage condition. When stored, the connector 9 is attached to thehandle 8 and the intermittent urinary catheter 2 is thus completelyenclosed or encapsulated in the enclosure provided by the tubular filmelement 7, connector 9 and handle 8. The tip portion 5 is illustrated asbeing protected inside the connector 9 and handle 8 during storage.

FIG. 6 illustrates a detail of the attachment between the connector 9and the handle 8. FIG. 6 illustrates how the handle 8 and connector 9are attached to each other to provide a closed connection and provide aprotective cavity for the tip portion 5. The first and second snap-fitmeans 10 and 11 are also illustrated in FIG. 6.

FIG. 7 illustrates a layered structure 30 of a material suitable for useas a second inner package. Starting from the middle, the layer 31, is aSIBS layer. This is on each side covered by a layer 32 a and 32 b, whichis a combination of SIBS and PE. The outermost layers, 33 a, 33 b aremade of PE.

FIG. 8 illustrates a second inner package 1 when it is ready to be usedwith the handle 8 and connector 9 separated from each other and theintermittent urinary catheter ready for insertion. The tubular filmelement 7 can be seen as covering the intermittent urinary catheter 2for a majority of the entire length.

FIG. 14 illustrates a cross-sectional view of a urinary catheterassembly with a second inner package 1 packed and stored in a firstouter package 20. Like with the embodiment of FIGS. 1 and 2, the firstouter package 20 is made of film-material welded along the edges toprovide an enclosure 21 in which, the intermittent urinary catheter 2including the second inner package 1 in the form of a collapsible andflexible tubular film element 7 is stored during storage. Thecollapsible tubular film material 7 is attached to a handle 8 in theproximal end and to a connector 9 in the distal end. The handle 8 isclosed with a first closure 27 and the connector is closed with a secondclosure 28. The first and second closures 27, 28 and the flexible andcollapsible tubular film material 7 provide an enclosure 24 for theintermittent urinary catheter 2.

FIGS. 9A and 9B illustrate upper (FIG. 9A) and lower (FIG. 9B) fixturesfor use in testing collapse-force of the second inner package. The upperfixture 40 includes an upper plate 41 with a recess 42, which is adaptedto let the catheter pass unhindered through it, but which will provide ahold-down for a handle on the second inner package. The lower fixture 50includes a lower plate 51 with a hold 52 adapted for connecting aconnector on the catheter or the second inner package. The hold 52 willtypically be a cylindrical element with a steering pin standing up fromthe lower plate 51—typically perpendicular to the lower plate 51.

FIGS. 10A, 10B and 10C illustrate testing of the collapse-force in threedifferent points of the testing. FIG. 10A illustrates that the testingis ready to be performed, the second inner package 61 including thecatheter is mounted in the test-rig 60. FIG. 10B illustrates the secondinner package half-way through the test. FIG. 10C illustrates the secondinner package at the finishing of the test, i.e. when 30 cm of thecatheter 62 has been exposed.

EXAMPLES

The diffusion through materials follows Fick's law, as long as thematerial is under steady state, meaning that an equilibrium state hasoccurred between the material and the surroundings.

Fick's law states that the amount, M of material (e.g. water molecules)that flows through a cross-section of material, S of a barrier materialover time, t is known as the flux, J:

$J = \frac{\partial M}{S \cdot {\partial t}}$

This equation can be re-written particularly with the purpose of gassespassing through a material:

$R = \frac{D \cdot A \cdot p}{d}$

In this equation, R is the diffusion rate (given in g/mm/time), D is adiffusion constant corresponding to the water vapour transmission rate(WVTR), A is the area over which diffusion occurs, p is the pressuredifference (difference in RH) across the material, and d is the distanceover which the diffusion may occur. This means that the barrier flow perday (BF) from a package including liquid given in mass per time unit canbe calculated as follows:

BF=WVTR·A·p

WVTR should in this equation be given in g/(m²·24 h), the area A shouldbe given in m² and p should be given as the % difference in relativehumidity, RH.

In this disclosure, a double-package comprising a first outer packageand a second inner package may be depicted.

The barrier flow (BF) through such a double-package is calculated usingthe following formula:

${{{BF}({system})} = \frac{1}{\frac{1}{{BF}({outer})} + \frac{1}{{BF}({inner})}}};$

where BF(system) is the barrier flow through the double package,BF(outer) is the barrier flow through the outer package and BF(inner) isthe barrier flow through the inner package. The barrier flow is measuredin g/24 h.

Thus, if the barrier flow through each of the packages (the first outerpackage and the second inner package) is known, e.g. determinedaccording to Fick's law, the barrier flow through the double package canbe calculated using this formula.

One object of this invention is to keep the RH-value in the intermediatecavity between a second inner package and a first outer package below90%. Using the above equations and understanding, the RH-value in thisintermediate cavity can be calculated as follows:

${{{RH}({cavity})} = {{{RH}({storage})} + {\left( {100 - {{RH}({storage})}} \right) \cdot \frac{\frac{1}{{BF}({outer})}}{\frac{1}{{BF}({outer})} + \frac{1}{{BF}({inner})}}}}};$

wherein BF(outer) is the barrier flow through the first outer packagegiven in g/24 h, BF(inner) is the barrier flow through the second innerpackage given in g/24 h, RH(cavity) is the absolute RH-value in theintermediate cavity and RH(storage) is the absolute RH-value at thestorage location external to the first outer package.

The tests mentioned below are performed by determining the water vapourpermeability (the barrier flow) through a material used for the secondinner package using test method A described here. According to testmethod A, the water vapour permeability is determined by enclosing anamount of liquid in test-package made of a test-material and leavingthis test-package in a conditioned environment, e.g. 65% RH, i.e. adifference between absolute RH value on either side of the test materialof 65%, and 30° C. until the water vapour transmission per 24 h issteady. The test-package is made as illustrated in FIG. 5. The secondinner package is made of a tubular material, which in a flattenedcondition has a width of 16.5 mm, corresponding to a diameter ofapproximately 10 mm. The water vapour transmission being steady isdetermined by weighing the test-packages once a day for a period of upto 2 weeks. In the first few days, there may be a situation where thetest-packages are not in a steady state—therefore, weighing over atleast 10 days but up to 2 weeks is preferred. Plotting the weight-lossper day clearly reveals when the steady state has occurred; an examplecan be seen in FIG. 11. In this figure, it is clear that the upper curveindicates a steady state having been reached within 1-2 days frominitiation of test. The lower curve, on the other hand, indicates thatit has taken 7 days before steady state having been reached. From thissteady state and onwards, the slope on the curve corresponds to thebarrier flow per 24 h measured in g/24 h. Dividing this with the areathrough which the flow occurs, provides a value for the water vapourtransmission rate WVTR.

The RH-value in the intermediate cavity can be calculated as follows:

${{{RH}({int})} = {{RH} + {\left( {100 - {RH}} \right) \cdot \frac{\frac{1}{{BF}({outer})}}{\frac{1}{{BF}({outer})} + \frac{1}{{BF}({inner})}}}}};$

where RH(int) is the relative humidity value in the intermediate cavityin percentage, which in embodiments of this disclosure is below 90%. RHis the value of the relative humidity outside of the double package,BF(outer) is the barrier flow through the first outer package andBF(inner) is the barrier flow through the second inner package.

Test of Water Vapour Transmission Rate

The water vapour transmission rate was tested according to the methodsdescribed above. More particularly, the water vapour transmission ratefor materials for the first outer package were tested according to ASTMF1249-13 at 90% RH and 38° C., and the water vapour transmission ratefor materials for the second inner package were tested using test methodA described above at 65% RH and 30° C. The following materials andobtained values are given below:

First Outer Package:

ID Material WVTR-value (g/(m² · 24 h)) 1a PETP 12/PE 80 4.5 2a OPA 12/PE100 3.7 3a PETP 12/PETP 12/PE 60 5.0 4a PETP12/PETP 12/PE 60 5.3 5a PETP12/PETP 12/PE 65 2.1

Specimen ID 1a is a laminate material comprising an outer layer of PETPof a thickness of 12 μm and an inner layer of PE of a thickness of 80μm.

Specimen ID 2a is a laminate material with an outer layer of OPA of 12μm and an inner layer of PE of a thickness of 100 μm.

Specimen ID 3a is a laminate material with two layers of PETP of 12 μmeach and an inner layer of PE of a thickness of 60 μm.

Specimen ID 4a is a laminate material with two layers of PETP of 12 μmeach and an inner layer of PE of a thickness of 60 μm.

Specimen ID 5a is a laminate material with two layers of PETP of 12 μmeach and an inner layer of PE of a thickness of 65 μm.

Second Inner Package:

ID Material WVTR-value (g/(m² · 24 h)) 1b 5 layer film, PE + SIBS, 60 μm1.59 2b PE 50 μm 3.05 3b 5 layer film, PE + SIBS, 70 μm 1.47

Specimen ID 1b is a 5 layer film-material, where the three innermostlayers are SIBS, and the outer layers are PE from the brand Queo® fromBorealis. The total thickness is 60 μm.

Specimen ID 2b is a three-layer film-material of PE from the brand Queo®from Borealis.

Specimen ID 3b is a 5 layer film-material, where the innermost layer isSIBS, the layers covering this innermost layer are a blend of PE andSIBS of the brand Queo® from Borealis, and the outer layers are PE alsofrom the brand Queo® from Borealis. The total thickness is 70 μm.

FIG. 12 illustrates the area between two curves that provides acceptablecorrespondence between WVTR values of the first outer package and WVTRvalues of the second inner package. The WVTR values are given ing/(m²·24 h). The WVTR values of the first outer package are measuredaccording to ASTM F1249 at 38° C. and 90% RH, whereas the WVTR values ofthe second inner package are measured according to test method A asdescribed above, at 30° C. and 65% RH. The linear curve sets thehumidity condition, which is that the value of the relative humidity(RH) in the intermediate cavity between the inner surface of the firstouter package and the outer surface of the second inner package, i.e.the absolute RH value inside the cavity, should be below 90%. Theexponentially decreasing curve sets the shelf-life of the doublepackage. The shelf-life is set to be at least 2 years, meaning thatthere should be liquid left in the package after two years. In thetests, it was depicted that 16 ml of liquid was included in the packageand that half of this was allowed to evaporate over 2 years.

Towards the right is indicated the possibility of having the secondinner package very close to completely water vapour impermeable—meaningthat the second inner package provides the barrier for preventing liquidfrom evaporation from the second inner package. Towards the top isindicated the opposite situation, namely that first outer packageprovides the barrier for liquid evaporation. This situation, the firstouter package provides the barrier, is not part of the embodiments ofthis disclosure. The embodiments of this disclosure are in the areabetween (under) the two curves indicated by the two arrows pointing intowards this area and the text “shelf-life ok” and “<90% RH ok”. In FIG.12, the first outer package has a surface area of approximately 37000mm². The second inner package has a surface area of approximately 12000mm². The green dot lying below the curves (at a WVTR value of 2 for thefirst outer package and 1.5 for the second inner package) indicates anexample of packages falling within the scope of the embodiments of thisdisclosure. The red dot lying to the right and above the curve (at aWVTR value of 5 for the second inner package and 1.5 for the first outerpackage) indicates an example of a double package falling outside thescope of the embodiments of this disclosure.

The linear curve in FIG. 12 accordingly represents combinations of WVTRvalues for the second inner package and WVTR values for the first outerpackage which result in an absolute RH value inside the cavity of 90%.Thus, the slope of the linear curve in FIG. 12 represents a ratiobetween WVTR values for the second inner package and WVTR values for thefirst outer package, which result in an absolute RH value inside thecavity of exactly 90%, with the specified surface areas of the packages.Ratios of inner and outer WVTR values below the linear curve result inabsolute RH values inside the intermediate cavity being below 90%. The90%-RH ratio for the embodiment of FIG. 12 having the first outerpackage surface area of approximately 37000 mm² and second inner packagesurface area of approximately 12000 mm² is approximately 2.2, while theratio between the surface area of the first outer package and secondinner package is approximately 3.1. As seen above, the relative humidityin the intermediate cavity depends also on the surface area of thesecond inner and the first outer package. Taking account of thisdependency may be achieved by dividing the 90%-RH ratio with the ratiobetween the surface area of the first outer package and second innerpackage, which yields a value of approximately 0.71. This valuecorresponds to a normalised 90%-RH ratio between WVTR values for thesecond inner package and WVTR values for the first outer package forwhich an intermediate cavity relative humidity of 90% taking intoaccount the difference in surface areas of the second inner and thefirst outer package.

FIG. 13 illustrates another embodiment of a combination of a first outerpackage and a second inner package. In this embodiment, the first outerpackage is smaller than the one shown in FIG. 12. In FIG. 13, the firstouter package has a surface area of approximately 20500 mm². Like inFIG. 12, the second inner package has a surface area of approximately12000 mm². The green dot lying below the curves (at a WVTR value of 4for the first outer package and 1.5 for the second inner package)indicates an example of packages falling within the scope of theembodiments of this disclosure. The red dot lying to the left and abovethe curves (at a WVTR value of 2 for the second inner package and above3 for the first outer package) indicates an example of a double packagefalling outside the scope of the embodiments of this disclosure. The90%-ratio, as defined above, for the FIG. 13 embodiment having a firstouter package surface area of approximately 20500 mm² and a second innerpackage surface area of approximately 12000 mm² is approximately 1.2,while the ratio between the surface area of the first outer package andsecond inner package is approximately 1.7. Again, dividing the 90%-RHratio with the ratio between the surface area of the first outer packageand second inner package may be done in order to take into account thedifference in surface areas of the first outer and the second innerpackage, and yields the same value of approximately 0.71 as for theembodiment illustrated in FIG. 12. Accordingly, the normalised 90%-RHratio is the same for the embodiment of FIG. 12 and the embodiment ofFIG. 13, confirming that the normalised 90%-RH ratio indeed takes intoaccount the difference in surface areas of the first inner and thesecond outer packages.

EXAMPLES

Referring to the tables above, the specimen IDs in the tables and FIGS.12 and 13, examples of combinations of first outer packages and secondinner packages are given below.

Example 1

The first outer package is made of a material corresponding to specimen2a with a WVTR value of 3.7 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 3b with a WVTR-value of1.47 g/(m²·24 h). The first outer package has a surface area of 37000mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 12. Theexample is indicated in FIG. 12. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 3.7g/(m²·24 h) for the first outer package and 1.47 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 2

The first outer package is made of a material corresponding to specimen5a with a WVTR value of 2.1 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 37000mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 12. Theexample is indicated in FIG. 12. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 2.1g/(m²·24 h) for the first outer package and 1.59 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 3

The first outer package is made of a material corresponding to specimen5a with a WVTR value of 2.1 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 2b with a WVTR-value of3.05 g/(m²·24 h). The first outer package has a surface area of 37000mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 12. Theexample is indicated in FIG. 12. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 2.1g/(m²·24 h) for the first outer package and 3.05 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 4

The first outer package is made of a material corresponding to specimen5a with a WVTR value of 2.1 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 3b with a WVTR-value of1.47 g/(m²·24 h). The first outer package has a surface area of 37000mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 12. Theexample is indicated in FIG. 12. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 2.1g/(m²·24 h) for the first outer package and 1.47 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 5

The first outer package is made of a material corresponding to specimen1a with a WVTR value of 4.5 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 20500mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 13. Theexample is indicated in FIG. 13. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 4.5g/(m²·24 h) for the first outer package and 1.59 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 6

The first outer package is made of a material corresponding to specimen2a with a WVTR value of 3.7 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 20500mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 13. Theexample is indicated in FIG. 13. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 3.7g/(m²·24 h) for the first outer package and 1.59 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 7

The first outer package is made of a material corresponding to specimen3a with a WVTR value of 5.0 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 20500mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 13. Theexample is indicated in FIG. 13. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 5.0g/(m²·24 h) for the first outer package and 1.59 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 8

The first outer package is made of a material corresponding to specimen4a with a WVTR value of 5.3 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 20500mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 13. Theexample is indicated in FIG. 13. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 5.3g/(m²·24 h) for the first outer package and 1.59 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 9

The first outer package is made of a material corresponding to specimen5a with a WVTR value of 2.1 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 20500mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 13. Theexample is indicated in FIG. 13. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 2.1g/(m²·24 h) for the first outer package and 1.59 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Example 10

The first outer package is made of a material corresponding to specimen2a with a WVTR value of 3.7 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 2b with a WVTR-value of3.05 g/(m²·24 h). The first outer package has a surface area of 20500mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 13. Theexample is indicated in FIG. 13. This example will provide a catheterassembly having a balanced diffusion through the first outer package, sothat the relative humidity (RH) in the intermediate cavity, i.e. theabsolute RH value inside the intermediate cavity, is below 90%.Furthermore, the shelf life for such an assembly will also be okay,because the crossing between the lines indicating the WVTR of 3.7g/(m²·24 h) for the first outer package and 3.05 g/(m²·24 h) for thesecond inner package is below the exponential curve for the shelf-life.

Examples 11-15

In these examples, the second inner package is made of a materialcorresponding to specimen 3b with a WVTR value of 1.47 g/(m²·24 h). Thefirst outer package has a surface area of 20500 mm² and the second innerpackage has a surface area of approximately 12000 mm², corresponding tothe curves illustrated in FIG. 13.

The variation between the examples 11-15 is in the material of the firstouter package, which varies from specimen 1a to 5a. It is clear fromFIG. 13 that all of these examples fulfil the requirements with respectto relative humidity and shelf-life, because the intersections betweenthe curve indicating a second inner package with a WVTR value of 1.47and the WVTR values of specimens 1a to 5a all are positioned below theexponential curve of the shelf-life and to the right of the curveindicating RH below 90%.

COMPARATIVE EXAMPLES

The first outer package is made of a material corresponding to specimen1a with a WVTR value of 4.5 g/(m²·24 h) and the second inner package ismade of a material corresponding to specimen 1b with a WVTR-value of1.59 g/(m²·24 h). The first outer package has a surface area of 37000mm² and the second inner package has a surface area of approximately12000 mm², corresponding to the curves illustrated in FIG. 12. Thisexample will provide a catheter assembly having a balanced diffusionthrough the first outer package, so that the relative humidity (RH) inthe intermediate cavity, i.e. the absolute RH value inside theintermediate cavity, is below 90%. However, the shelf-life will notfulfil the requirement of two years, because too much liquid willevaporate. This is clear from FIG. 12, because the cross-point between4.5 on the X-axis and 1.59 on the Y-axis will be above the exponentialcurve of the shelf-life.

It is further clear from FIG. 12 that combining a first outer package ofa material corresponding to specimens 3a or 4a having a WVTR value thatis higher than specimen 1a with a second inner package of a materialcorresponding to specimen 1b (with a WVTR value of 1.59 g/(m²·24 h))will lead to assemblies having a shelf life that is not acceptable. Asmentioned above, the cross points between 5.0 and 1.59 and 5.3 and 1.59will be above the exponential curve indicating the acceptableshelf-life.

In another comparative example, the first outer package is made of amaterial corresponding to specimen 1a with a WVTR value of 4.5 g/(m²·24h) and the second inner package is made of a material corresponding tospecimen 2b with a WVTR-value of 3.05 g/(m²·24 h). The first outerpackage has a surface area of 20500 mm² and the second inner package hasa surface area of approximately 12000 mm², corresponding to the curvesillustrated in FIG. 13. This example will provide a catheter assemblyhaving a balanced diffusion through the first outer package, so that therelative humidity (RH) in the intermediate cavity, i.e. the absolute RHvalue inside the intermediate cavity, is below 90%. However, theshelf-life will not fulfil the requirement of two years, because toomuch liquid will evaporate. This is clear from FIG. 13, because thecross-point between 4.5 on the X-axis and 3.05 on the Y-axis will beabove the exponential curve of the shelf-life.

It is further clear from FIG. 13 that combining a first outer package ofa material corresponding to specimens 3a or 4a having a WVTR value thatis higher than specimen 1a with a second inner package of a materialcorresponding to specimen 1b (with a WVTR value of 3.05 g/(m²·24 h))will lead to assemblies having a shelf life that is not acceptable. Asmentioned above, the cross points between 5.0 and 3.05 and 5.3 and 3.05will be above the exponential curve indicating the acceptableshelf-life.

In a further comparative example, the first outer package is made of amaterial corresponding to specimen 5a with a WVTR value of 2.1 g/(m²·24h) and the second inner package is made of a material corresponding tospecimen 2b with a WVTR-value of 3.05 g/(m²·24 h). The first outerpackage has a surface area of 20500 mm² and the second inner package hasa surface area of approximately 12000 mm², corresponding to the curvesillustrated in FIG. 13. This example will provide a catheter assemblyhaving a too low diffusion, meaning that the relative humidity (RH) inthe intermediate cavity is above 90%. The shelf-life will fulfil therequirement of two years. This is clear from FIG. 13, because thecross-point between 2.1 on the X-axis and 3.05 on the Y-axis will beabove the curve indicating the RH-level of 90%. This means that for suchan assembly, there is a risk that the condensed liquid inside theintermediate cavity will not evaporate and therefore the second innerpackage may have a wet surface so that it is not as easy to handle.

Test of Collapse-Force

The collapse-force was tested in accordance with test method B asdescribed below. The collapse-force was tested on test-specimens ofsecond inner package, where the second inner package is in the form of asleeve as illustrated for example in FIGS. 3, 4 and 8. In the fullyextended state of the sleeve, prior to the test being performed, thesleeve had a length of approximately 340 mm, corresponding to the lengthof a sleeve applied to a male catheter. The equipment used was anInstron tensile tester. For further reference, see FIGS. 9 and 10. Testmethod B includes the following steps:

-   -   1. Place the catheter with the second inner package on a        supporting bar with the connector in contact with the supporting        bar.    -   2. Move the upper fixture down, so the lower end of the fixture,        is in the middle of the lowest (the distal) eyelet.    -   3. Make a zero point setting on the equipment (with the upper        fixture, but without the catheter touching the upper fixture).    -   4. Start the test. The upper fixture is now moving down. The        sleeve is being pushed down, while the catheter is not moving.    -   5. Note the compression load after 300 mm.

The compression load corresponds to the collapse-force and is noted inN.

The table below gives examples of collapse-forces tested:

ID Material Collapse-force (N) 1c PE/SIBS multilayer film 2.97N 2c PE 28μm 2.4N 3c PE 50 μm 2.92 4c PE/SIBS multilayer film, 60 μm 2.11 5cPE/SIBS multilayer film 80 μm 10.13N 6c PE/SIBS multilayer film 80 μm12.73N

Specimen ID 1c is a 5 layer film-material, where the innermost layer isSIBS, the layers covering this innermost layer are a blend of PE andSIBS of the brand Queo® from Borealis, and the outer layers are PE alsofrom the brand Queo® from Borealis. The total thickness is 70 μm. Thiscorresponds to specimen 3b above.

Specimen ID 2c is a one-layer film-material of PE from the brand Queo®from Borealis.

Specimen ID 3c is a three-layer film-material of PE from the brand Queo®from Borealis. This corresponds to specimen 2b above.

Specimen ID 4c is a 5 layer film-material, where the three innermostlayers are SIBS, and the outer layers are PE from the brand Queo® fromBorealis. The total thickness is 60 μm. This corresponds to specimen 1babove.

Specimen ID 5c is a 5 layer film-material, where three innermost layersare a blend of PE and SIBS of the brand Queo® from Borealis, and theouter layers are PE from the brand Eltex. The total thickness is 80 μm.

Specimen ID 6c is a 5 layer film-material, where the three innermostlayers are a blend of PE and SIBS of the brand Eltex® from Ineos, andthe outer layers are PE also from the brand Eltex® from Ineos. The totalthickness is 80 μm.

The tests illustrate that specimens 1c, 2c, 3c and 4c all have acollapse-force, measured according to test method B as described above,which is below 3 N. This means that all of these sleeves are easilycollapsible to the extent that even users having very poor handdexterity will find them very easy to handle, due to the lowcollapse-force. Specimens 5c and 6c on the other hand, have a quite highcollapse-force—and will thus be more difficult to collapse for usershaving poor hand dexterity.

EMBODIMENTS

1. A urinary catheter assembly comprising a first outer package of afirst material, the outer package contains a second inner package of asecond material, an intermediate cavity defined as an area inside thefirst outer package and outside the second inner package, the secondinner package defining an enclosure, the enclosure containing anintermittent urinary catheter with a hydrophilic coating and a swellingmedium, wherein the permeability of the outer package and the innerpackage is balanced in such a way that the RH value is below 90% in theintermediate cavity.

2. A urinary catheter assembly comprising a first outer package of afirst material, the first material having a first water vapourtransmission rate (WVTR), the first outer package contains a secondinner package of a second material, the second material having a secondwater vapour transmission rate (WVTR);

an intermediate cavity defined as an area inside the first outer packageand outside the second inner package, the second inner package definingan enclosure, the enclosure containing an intermittent urinary catheterwith a hydrophilic coating, and a swelling medium;

wherein the relationship between the first and second water vapourtransmissions are such that they fulfil the following equations:

  BF(outer) = WVTR(outer) ⋅ A(outer) ⋅ p  BF(inner) = WVTR(inner) ⋅ A(inner) ⋅ p${{{RH}({cavity})} = {{{{RH}({storage})} + {\left( {100 - {{RH}({storage})}} \right) \cdot \frac{\frac{1}{{BF}({outer})}}{\frac{1}{{BF}({outer})} + \frac{1}{{BF}({inner})}}}} < {90\%}}};$

wherein BF(outer) is the barrier flow through the first outer packagegiven in g/24 h, BF(inner) is the barrier flow through the second innerpackage given in g/24 h, WVTR(outer) is the first water vapourtransmission rate and WVTR(inner) is the second water vapourtransmission rate, A(inner) is the surface area of the first outerpackage, A(outer) is the surface area of the second inner package and pis the difference in RH value between the ambience and the inside of thepackage.

3. A urinary catheter assembly comprising a first outer package of afirst material, the first material having a first water vapourtransmission rate (WVTR), the first outer package contains a secondinner package of a second material, the second material having a secondwater vapour transmission rate (WVTR);

an intermediate cavity defined as an area inside the first outer packageand outside the second inner package, the second inner package definingan enclosure, the enclosure containing an intermittent urinary catheterwith a hydrophilic coating, and a swelling medium;

wherein the relationship between the first and second water vapourtransmissions are such that they fulfil the following equations:

  BF(outer) = WVTR(outer) ⋅ A(outer) ⋅ p(outer)  BF(inner) = WVTR(inner) ⋅ A(inner) ⋅ p(inner)${{{RH}({cavity})} = {{{{RH}({storage})} + {\left( {100 - {{RH}({storage})}} \right) \cdot \frac{\frac{1}{{BF}({outer})}}{\frac{1}{{BF}({outer})} + \frac{1}{{BF}({inner})}}}} < {90\%}}};$

wherein BF(outer) is the barrier flow through the first outer packagegiven in g/24 h, BF(inner) is the barrier flow through the second innerpackage given in g/24 h, WVTR(outer) is the first water vapourtransmission rate and WVTR(inner) is the second water vapourtransmission rate, A(inner) is the surface area of the first outerpackage, A(outer) is the surface area of the second inner package,p(outer) is the difference in RH-value between the ambience and theintermediate cavity, p(inner) is the difference in RH-value between thesecond inner package and the intermediate cavity, RH(cavity) is theRH-value in the intermediate cavity and RH(storage) is the RH-value atthe storage location external to the first outer package.

4. A urinary catheter assembly comprising a first outer package of afirst material, the first material having a first water vapourtransmission rate (WVTR) measured according to ASTM F1249 at 90% RH and38° C. between 1 g/(m²·24 h) and 6 g/(m²·24 h), the first outer packagecontains a second inner package of a second material, the secondmaterial having a second water vapour transmission rate (WVTR) measuredaccording to test method A as described herein at 65% RH and 30° C.below 3 g/(m²·24 h);

an intermediate cavity defined as an area inside the first outer packageand outside the second inner package, the second inner package definingan enclosure, the enclosure containing an intermittent urinary catheterwith a hydrophilic coating, and a swelling medium;

wherein the first water vapour transmission rate and the second watervapour transmission rate are balanced in such a way that the relativehumidity (RH) value is below 90% in the intermediate cavity

5. A urinary catheter assembly comprising a first outer package (20) ofa first material, the first material having a first water vapourtransmission rate (WVTR) measured according to ASTM F1249 at 90% RH and38° C. between 1 g/(m²·24 h) and 6 g/(m²·24 h), the first outer package(20) contains a second inner package (1) of a second material, thesecond material having a second water vapour transmission rate (WVTR)measured according to test method A as described herein at 65% RH and30° C. below 3 g/(m²·24 h);

an intermediate cavity (22, 25) defined as an area inside the firstouter package (20) and outside the second inner package (1), the secondinner package (1) defining an enclosure (21, 24), the enclosure (21, 24)containing an intermittent urinary catheter (2) with a hydrophiliccoating, and a swelling medium;

wherein the first water vapour transmission rate and the second watervapour transmission rate are balanced in such a way that the relativehumidity (RH) value is below 90% in the intermediate cavity (22, 25) andwherein the second inner package (1) is made of a multilayer filmmaterial comprising layers of Polyethylene (PE) and layers ofStyrene-IsoButylene-Styrene (SIBS) and/or layers of combinations of PEand SIBS.

6. A urinary catheter assembly comprising a first outer package (20) ofa first material, the first material having a first water vapourtransmission rate (WVTR) measured according to ASTM F1249 at 90% RH and38° C. between 1 g/(m²·24 h) and 6 g/(m²·24 h), the first outer package(20) contains a second inner package (1) of a second material, thesecond material having a second water vapour transmission rate (WVTR)measured according to test method A as described herein at 65% RH and30° C. below 3 g/(m²·24 h);

an intermediate cavity (22, 25) defined as an area inside the firstouter package (20) and outside the second inner package (1), the secondinner package (1) defining an enclosure (21, 24), the enclosure (21, 24)containing an intermittent urinary catheter (2) with a hydrophiliccoating, and a swelling medium;

wherein the second inner package (1) comprises a tubular film element(7), which has a collapse-force measured according to test method B asdescribed herein, being no larger than 6 N.

7. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first outer package has a first watervapour transmission rate measured as described here at 65% RH and 30° C.above 3 g/(m²·24 h).

8. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package has a secondwater vapour transmission rate measured according to test method A asdescribed herein at 65% RH and 30° C. below 2 g/(m²·24 h).

9. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is of tubularform and provides a close-fit about the catheter.

10. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package has a diameterof 20 mm, but may be less such as 16 mm, 12 mm or 10 mm or even 9 mm.

11. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is closed with afirst closure in the proximal end.

12. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is closed with asecond closure in the distal end.

13. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first closure is a plug.

14. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second closure is a plug.

15. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first closure is a peel-weldedclosure.

16. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second closure is a peel-weldedclosure

17. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the RH value in the intermediate cavityis below 85%.

18. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the RH value in the intermediate cavityis below 80%.

19. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first outer package is made of afilm-material.

20. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first outer package is made of afilm-material and is welded for providing an enclosure.

21. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first outer package is made of amultiple layer film material of a laminate of PETP and PE.

22. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is made of amultiple layer film material of a laminate of PETP, PE and SIBS.

23. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is useable as aninsertion aid.

24. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package has acollapsibility such that the force used to compress the inner package toexpose 30 cm is below 6 N.

25. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first outer package is made of afilm-material with a thickness below 200 μm.

26. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the first outer package is made of amultilayer film-material with a thickness below 200 μm.

27. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is made of afilm-material with a thickness below 200 μm.

28. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the second inner package is made of amultilayer film-material with a thickness below 200 μm.

29. The intermittent urinary catheter assembly according to any of thepreceding embodiments, wherein the tip portion is a flex tip.

30. A urinary catheter assembly according to any of the precedingembodiments, wherein the second inner package comprises a tubular filmelement, which is easily collapsible to an extent where at least 30 cmfrom the proximal end of a male catheter can be exposed withoutnoticeable resistance.

1. A urinary catheter assembly comprising a first outer package (20) ofa first material, the first material having a first water vapourtransmission rate (WVTR) measured according to ASTM F1249 at 90% RH and38° C. between 1 g/(m²·24 h) and 6 g/(m²·24 h), the first outer package(20) contains a second inner package (1) of a second material, thesecond material having a second water vapour transmission rate (WVTR)measured according to test method A as described herein at 65% RH and30° C. below 3 g/(m²·24 h); an intermediate cavity (22, 25) defined asan area inside the first outer package (20) and outside the second innerpackage (1), the second inner package (1) defining an enclosure (21,24), the enclosure (21, 24) containing an intermittent urinary catheter(2) with a hydrophilic coating, and a swelling medium.
 2. A urinarycatheter assembly according to claim 1, wherein the first water vapourtransmission rate and the second water vapour transmission rate arebalanced in such a way that the relative humidity (RH) value is below90% in the intermediate cavity (22, 25).
 3. A urinary catheter assemblyaccording to claim 1 or 2, wherein the second inner package (1) is madeof a multilayer film material comprising layers of Polyethylene (PE) andlayers of Styrene-IsoButylene-Styrene (SIBS) and/or layers ofcombinations of PE and SIBS.
 4. A urinary catheter assembly according toany of the preceding claims, wherein the first outer package (20)defines a first outer package surface area, the second inner package (1)defines a second inner package surface area, a surface area ratio isdefined as the second inner package surface area divided by first outerpackage surface area, a WVTR ratio is defined as the second WVTR dividedby the first WVTR, and wherein the WVTR ratio is no larger than 0.7times the surface area ratio.
 5. A urinary catheter assembly accordingto claim 4, wherein the WVTR ratio is no larger than 0.6 times thesurface area ratio.
 6. A urinary catheter assembly according to any ofthe preceding claims, wherein the second inner package (1) is made of aflexible and collapsible film-material.
 7. A urinary catheter assemblyaccording to any of the preceding claims, wherein the first outerpackage (20) is made of a film-material that is welded along the edges.8. A urinary catheter assembly according to any of the preceding claims,wherein the second inner package (1) is of tubular form and providing aclose-fit about the catheter.
 9. A urinary catheter assembly accordingto any of the preceding claims, wherein the second inner package (1)comprises a handle (8) slidingly disposed on the intermittent urinarycatheter (2) and a collapsible and flexible tubular film element (7),which is attached to the handle (8) and which is configured to cover theintermittent urinary catheter (2) from an outlet to an insertion tip inan extended configuration, the tubular film element (7) being attachedto a connector (9) at the outlet, wherein the collapsible and flexibletubular film element is configured for being closed at the handle and atthe connector.
 10. A urinary catheter assembly according to claim 9,wherein the connector (9) and handle (8) are configured to be attachedto each other in a detachable manner, so that when the connector (9) andhandle (8) are attached to each other, the intermittent urinary catheter(2) is encapsulated completely inside the enclosure (21, 24) provided bythe second inner package (1) comprising the tubular film element (7),the handle (8) and the connector (9).
 11. A urinary catheter assemblyaccording to claim 9 or 10, wherein the collapsible and flexible tubularfilm element (7) is closed with a first closure in the proximal end andthe collapsible and flexible tubular film element (7) is closed with asecond closure in the distal end.
 12. A urinary catheter assemblyaccording to any of the preceding claims, wherein the first outerpackage (20) is made of a multiple layer film material of a laminate ofPolyethylene terephthalate (PETP) and Polyethylene (PE).
 13. A urinarycatheter assembly according to any of the preceding claims, wherein thematerial of the second inner package (1) is a 5 layer film-materialcomprising a SIBS layer in the middle, which on each side is covered bya layer made of PE and SIBS and where the outer layers are made of PE.14. A urinary catheter assembly according to any of the precedingclaims, wherein the second inner package (1) is useable as an insertionaid.
 15. A urinary catheter assembly according to any of the precedingclaims, wherein the second inner package (1) comprises a tubular filmelement (7), which has a collapse-force, measured according to testmethod B as described herein, being no larger than 6 N.
 16. A urinarycatheter assembly according to claim 15, wherein the tubular filmelement (7) has a collapse-force, measured according to test method B asdescribed herein, being no larger than 3 N.
 17. A urinary catheterassembly according to any of the preceding claims, wherein the secondinner package (1) is provided in an annular closed-loop configurationcontained inside the first outer package (20) and wherein the first WVTRvalue of the first outer package is between 1 g/(m²·24 h) and 3 g/(m²·24h) measured according to ASTM F1249 at 38° C. and 90% RH.
 18. A urinarycatheter assembly according to any of the preceding claims, wherein thesecond inner package (1) is provided in rolled-up configuration with twoconvolutions contained inside the first outer package (20) and whereinthe first WVTR value of the first outer package is between 4 g/(m²·24 h)and 6 g/(m²·24 h) measured according to ASTM F1249 at 38° C. and 90% RH.19. A urinary catheter assembly according to any of the precedingclaims, wherein the shelf life of the urinary catheter assembly is atleast two years.